HRP20050077B1 - Methods and dosage forms for controlled delivery of paliperidone - Google Patents
Methods and dosage forms for controlled delivery of paliperidoneInfo
- Publication number
- HRP20050077B1 HRP20050077B1 HRP20050077AA HRP20050077A HRP20050077B1 HR P20050077 B1 HRP20050077 B1 HR P20050077B1 HR P20050077A A HRP20050077A A HR P20050077AA HR P20050077 A HRP20050077 A HR P20050077A HR P20050077 B1 HRP20050077 B1 HR P20050077B1
- Authority
- HR
- Croatia
- Prior art keywords
- paliperidone
- concentrations
- dosage forms
- methods
- dosage form
- Prior art date
Links
- PMXMIIMHBWHSKN-UHFFFAOYSA-N 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC=3C(=O)N4CCCC(O)C4=NC=3C)=NOC2=C1 PMXMIIMHBWHSKN-UHFFFAOYSA-N 0.000 title abstract 7
- 229960001057 paliperidone Drugs 0.000 title abstract 7
- 239000002552 dosage form Substances 0.000 title abstract 4
- 238000000034 method Methods 0.000 title abstract 2
- 239000012729 immediate-release (IR) formulation Substances 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants
Landscapes
- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Abstract
Predstavljani su oblici doziranja i postupci za omogućavanje pouzdano povećanih rata otpuštanja paliperidona. Postepeno otpuštanje oblika doziranja omogućuje terapeutski učinkovitih prosječnih stabilnih koncentracija paliperidona kad se administrira jednom dnevno. Ovaj režim doziranja jednom dnevno rezultira u samom pojavljivanju vršne koncentracije paliperidona u svakom 24-satnom razdoblju. K tome, vršna koncentracija paliperidona u plazmi javlja se u kasnijem razdoblju nakon administracije doze i ima manju magnitude nego vršna koncentracija paliperidona u plazmi koja nastupa nakon administracije paliperidona u obliku doziranja s trenutnim otpuštanjem.Dosage forms and procedures for reliably increasing paliperidone release rates are presented. Gradual release of the dosage form provides therapeutically effective average stable paliperidone concentrations when administered once daily. This once-daily dosing regimen results in the onset of peak paliperidone concentrations in each 24-hour period. In addition, peak plasma paliperidone concentrations occur at a later period after dose administration and have a lower magnitude than peak plasma paliperidone concentrations occurring after paliperidone administration in the immediate release dosage form.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US39959002P | 2002-07-29 | 2002-07-29 | |
US40600502P | 2002-08-26 | 2002-08-26 | |
PCT/US2003/023433 WO2004010981A1 (en) | 2002-07-29 | 2003-07-28 | Methods and dosage forms for controlled delivery of paliperidone |
Publications (2)
Publication Number | Publication Date |
---|---|
HRP20050077A2 HRP20050077A2 (en) | 2005-12-31 |
HRP20050077B1 true HRP20050077B1 (en) | 2013-11-22 |
Family
ID=31191280
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20050077AA HRP20050077B1 (en) | 2002-07-29 | 2005-01-25 | Methods and dosage forms for controlled delivery of paliperidone |
Country Status (29)
Country | Link |
---|---|
US (1) | US20040092534A1 (en) |
EP (1) | EP1539115B1 (en) |
JP (1) | JP4500679B2 (en) |
KR (1) | KR100699516B1 (en) |
CN (1) | CN1684670A (en) |
AR (1) | AR040721A1 (en) |
AT (1) | ATE373472T1 (en) |
AU (1) | AU2003256844A1 (en) |
BR (1) | BR0313139A (en) |
CA (1) | CA2494234C (en) |
CO (1) | CO5580742A2 (en) |
CY (1) | CY1107096T1 (en) |
DE (1) | DE60316454T2 (en) |
DK (1) | DK1539115T3 (en) |
ES (1) | ES2293039T3 (en) |
HK (1) | HK1072559A1 (en) |
HR (1) | HRP20050077B1 (en) |
IL (1) | IL166489A (en) |
MX (1) | MXPA05001191A (en) |
MY (1) | MY137049A (en) |
NO (1) | NO324821B1 (en) |
NZ (1) | NZ570198A (en) |
PE (1) | PE20040132A1 (en) |
PL (1) | PL210119B1 (en) |
PT (1) | PT1539115E (en) |
RU (1) | RU2321391C2 (en) |
TW (1) | TWI363637B (en) |
WO (1) | WO2004010981A1 (en) |
ZA (1) | ZA200501641B (en) |
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-
2003
- 2003-07-28 EP EP03771910A patent/EP1539115B1/en not_active Revoked
- 2003-07-28 MX MXPA05001191A patent/MXPA05001191A/en active IP Right Grant
- 2003-07-28 AU AU2003256844A patent/AU2003256844A1/en not_active Abandoned
- 2003-07-28 DE DE60316454T patent/DE60316454T2/en not_active Expired - Lifetime
- 2003-07-28 RU RU2005102105/15A patent/RU2321391C2/en not_active Application Discontinuation
- 2003-07-28 AT AT03771910T patent/ATE373472T1/en active
- 2003-07-28 KR KR1020057001460A patent/KR100699516B1/en active IP Right Review Request
- 2003-07-28 BR BR0313139-4A patent/BR0313139A/en not_active Application Discontinuation
- 2003-07-28 DK DK03771910T patent/DK1539115T3/en active
- 2003-07-28 PT PT03771910T patent/PT1539115E/en unknown
- 2003-07-28 US US10/629,211 patent/US20040092534A1/en not_active Abandoned
- 2003-07-28 CA CA002494234A patent/CA2494234C/en not_active Expired - Lifetime
- 2003-07-28 ES ES03771910T patent/ES2293039T3/en not_active Expired - Lifetime
- 2003-07-28 JP JP2004524886A patent/JP4500679B2/en not_active Expired - Lifetime
- 2003-07-28 WO PCT/US2003/023433 patent/WO2004010981A1/en active IP Right Grant
- 2003-07-28 NZ NZ570198A patent/NZ570198A/en not_active IP Right Cessation
- 2003-07-28 PL PL376258A patent/PL210119B1/en unknown
- 2003-07-28 CN CNA03822948XA patent/CN1684670A/en active Pending
- 2003-07-29 AR AR20030102717A patent/AR040721A1/en unknown
- 2003-07-29 TW TW092120703A patent/TWI363637B/en not_active IP Right Cessation
- 2003-07-29 MY MYPI20032846A patent/MY137049A/en unknown
- 2003-07-30 PE PE2003000749A patent/PE20040132A1/en not_active Application Discontinuation
-
2005
- 2005-01-25 HR HRP20050077AA patent/HRP20050077B1/en not_active IP Right Cessation
- 2005-01-25 IL IL166489A patent/IL166489A/en active IP Right Grant
- 2005-02-22 NO NO20050956A patent/NO324821B1/en not_active IP Right Cessation
- 2005-02-24 ZA ZA2005/01641A patent/ZA200501641B/en unknown
- 2005-02-28 CO CO05018509A patent/CO5580742A2/en not_active Application Discontinuation
- 2005-06-28 HK HK05105362A patent/HK1072559A1/en not_active IP Right Cessation
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2007
- 2007-12-18 CY CY20071101601T patent/CY1107096T1/en unknown
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO1997044039A1 (en) * | 1996-05-20 | 1997-11-27 | Janssen Pharmaceutica N.V. | Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters |
WO1999062496A1 (en) * | 1998-06-03 | 1999-12-09 | Alza Corporation | Methods and devices for providing prolonged drug therapy |
WO2000035419A2 (en) * | 1998-12-17 | 2000-06-22 | Alza Corporation | Conversion of liquid filled gelatin capsules into controlled release systems by multiple coatings |
US20020051807A1 (en) * | 2000-01-13 | 2002-05-02 | Joaquina Faour | Osmotic device containing alprazolam and an antipsychotic agent |
US20020035357A1 (en) * | 2000-01-14 | 2002-03-21 | Joaquina Faour | Osmotic device within an osmotic device |
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